The primary purpose of this study is to determine the effectiveness and safety of intravenous methylprednisolone in persons with suspected and proven hantavirus infection.

Condition	Intervention	Phase
Hantaviruses	Drug: Methylprednisolone D5W	Phase II

Further Study Details: 

Expected Total Enrollment:  60

Phase II, randomized, double-blind, placebo-controlled evaluation of intravenous methylprednisolone comparison of treatment with equal randomization between the two study groups. The study will require 60 subjects with confirmed hantavirus infection. Study subjects will include males and females >2 years of age suspected of having hantavirus disease. Following the completion of acute phase therapy (i.e. completion of all study drug), patients will be seen in follow-up visits at day 14, 28 and 84 and at 6 months after entry. Follow-up visits will include a physical examination, with vital signs included. In addition, blood will be drawn for a CBC with a differential, clinical chemistries, hantavirus serology, and quantitative PCR. Since hantavirus pathogeneisis involves the pulmonary system, other tests to be performed are chest x-ray, spirometry and oxygen saturation. Urinalysis will be performed on days 28.

Ages Eligible for Study:  2 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Confirmed diagnosis: Positive hantavirus IgM assay or detection of hantavirus in plasma or serum by RT-PCR in the presence of an acute febrile illness of less than 12 days duration, and

1. Onset of hypoxia (oxygen saturation <=92%) one or more days after onset of symptoms, and
2. Development of bilateral pulmonary infiltrates on chest X-ray. Presumptive diagnosis: The presumptive diagnosis of acute hantavirus disease of less than 12 days duration with:

a) Febrile illness (subjective or documented) in the judgment of the enrolling investigator; and b) Headache or myalgia or at least one digestive symptom (nausea, diarrhea, vomiting, abdominal pain) and c) A platelet count <150,000 and presence of immunoblasts* on peripheral smear; and d) Onset of hypoxia (oxygen saturation <=92%) one or more days after onset of symptoms, and e) Development of bilateral pulmonary infiltrates on chest X-ray

Exclusion Criteria:

Age less than 2 years. If presumptive diagnosis is the inclusion criteria: subjects with a likely diagnosis other than hantavirus infection, including any positive culture or direct test for respiratory viruses (e.g., influenza, RSV, etc) or group A Streptococcus in a person with an illness compatible with streptococcal pharyngitis, a positive culture from a normally sterile site, or a presentation consistent with bacterial pneumonia.

Immunocompromised patients at risk of opportunistic infection (e.g., patients with HIV infection, underlying malignancy, or who have received chemotherapy or immunosuppressive drugs within 30 days).

Patients who have or will receive any systemic antiviral medication (other than acyclovir, famciclovir, amantadine or rimantadine), systemic corticosteroids equivalent to approximately 0.5 mg/kg prednisone, or any investigational drug within 30 days before enrollment or during treatment.

Any period of extreme bradicardia, pulseless electric activity Patients with unilateral pulmonary infiltrates by chest X-ray that remain unilateral on a follow up chest X-ray at least 24 hours after the first X-ray.

Active GI bleeding, with hematemesis, melena or hematochezia or documented by upper or lower endoscopy or by gastric aspiration.

Please refer to this study by ClinicalTrials.gov identifier  NCT00128180

Pablo Vial      +562 2159330 x108    pvial@udd.cl

New Mexico
      University of New Mexico Infectious Diseases, Albuquerque,  New Mexico,  87131,  United States; No longer recruiting
Chile
      Universidad Catolica de Chile, Santiago,  Chile; Recruiting
      Hospital Rios Ruiz, Los Angeles,  Chile; Recruiting

Study ID Numbers:  01-010
Last Updated:  August 22, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128180
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23